Safety of Short-term Hydroxychloroquine Plus Azithromycin Treatment in Critically Ill Patients With Severe COVID-19

NCT04452617 | Completed

• 1 other identifier: REA-03-2020
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Hydroxychloroquine and azithromycin have been proposed as treatment of COVID-19 patients, but few reports have assessed this combination therapy in critically ill COVID-19 patients. Many raised concerns regarding the potential cardiac toxicity of this association. The purpose of this monocenter retrospective observational study is to evaluate the safety of a short term treatment with hydroxychloroquine and azithromycin in critically ill patients admitted in ICU for severe COVID-19 with respiratory failure. The main objective is to assess the incidence of severe cardiac arrhythmia e.g torsade de pointes and cardiac arrest or sudden death, during the treatment period.

Conditions

COVID-19

Keywords

hydroxychloroquine; ADRS; azithromycine; torsade de pointe

Outcome Measures

Primary Outcomes (1)

• occurrence of severe cardiac arrhythmia: torsade de pointes and cardiac arrest or sudden death

  30 days after admission in ICU

Secondary Outcomes (1)

• assessment of QTc interval prolongation during the treatment period compared to baseline ECG

  daily

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Critically ill patients admitted in ICU for severe COVID-19 with respiratory failure and a short term treatment with hydroxychloroquine (HCQ) and azithromycin (AZ): * HCQ administered at a daily dosage of 600mg in 3 doses for 10 days. * AZ administered at a dosage of 500mg on the first day and then 250mg/day for 4 to 6 days.

You may qualify if:

• critically ill patients admitted in ICU for severe COVID-19 with respiratory failure for at least two days of treatment with hydroxychloroquine and azithromycin.

You may not qualify if:

• cardiac conduction disorders
• continuous anti-arrhythmic therapy
• heart failure
• chronic renal failure

Sponsors & Collaborators

• Institut Mutualiste Montsouris: lead

Study Sites (1)

Institut Mutualiste Montsouris

Paris, 75014, France

Location

MeSH Terms

Conditions

COVID-19; Torsades de Pointes

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Tachycardia, Ventricular; Tachycardia; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Lyes KNANI, Doctor

  Institut Mutualiste Montsouris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2020
• First Posted: June 30, 2020
• Study Start: March 19, 2020
• Primary Completion: April 8, 2020
• Study Completion: July 1, 2020
• Last Updated: September 1, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)